{"schema_version":"secwatch.filing_event.v1","accession":"0001999371-25-017964","form_type":"8-K","ticker":"TNXP","cik":"0001430306","company_name":"Tonix Pharmaceuticals Holding Corp.","filed_at":"2025-11-17T23:59:59+00:00","discovered_at":"2026-05-14T18:02:39.392951+00:00","generated_at":"2026-05-16T19:10:30.689625+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Tonix launches TONMYA as first new fibromyalgia treatment in 15 years","bullets":["TONMYA (cyclobenzaprine HCl sublingual tablets) now available by prescription nationwide.","FDA approved Aug 15, 2025; first non-opioid once-daily bedtime analgesic for fibromyalgia.","Phase 3 trials (nearly 1,000 patients) showed significant pain reduction vs placebo at 14 weeks.","Most common side effects: oral hypoesthesia, somnolence, dry mouth."],"urls":{"canonical":"https://secwatch.observer/filing/0001999371-25-017964","json":"https://secwatch.observer/filing/0001999371-25-017964.json","markdown":"https://secwatch.observer/filing/0001999371-25-017964.md","text":"https://secwatch.observer/filing/0001999371-25-017964.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1430306/000199937125017964/0001999371-25-017964-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1430306/000199937125017964/tnxp-8k_111725.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T19:10:30.689625+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}